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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12619000184178p

Ethics application status

Submitted, not yet approved

Date submitted

2/02/2019

Date registered

8/02/2019

Date last updated

8/02/2019

Date data sharing statement initially provided

8/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Immunogenicity of oral polio vaccine in different doses in Mozambique

Scientific title

Comparison of Immunogenicity of mOPV2 administered as 1-drop or 2-drop oral dose to infants in Mocuba district, Mozambique, 2019

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

poliomyelitis

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Study arm A: one drop (reduced dose=0.05 mL) of monovalent oral poliovirus vaccine type 2 (mOPV2), containing half of 10^5 +/- 0.5 log TCID 50 (50% Tissue culture Infective Dose) of type 2 Sabin virus

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Prevention

Comparator / control treatment

Study arm B: two drops (normal dose=0.1 mL) of monovalent oral poliovirus vaccine type 2 (mOPV2) containing 10^5 +/- 0.5 log TCID 50 (50% Tissue culture Infective Dose) of type 2 Sabin virus

Control group

Dose comparison

Outcomes

Primary outcome [1]

Seroconversion after one full or reduced dose of mOPV2 expressed by increase in poliovirus type 2 antibodies assessed by neutralization assay test of sera

Timepoint [1]

Comparison of proportion of children who seroconverted 14 days after one or two drops of mOPV2 vaccine

Secondary outcome [1]

Titre of poliovirus type 2 neutralizing antibodies after one or two drops of mOPV2 assessed by neutralization assay test of sera

Timepoint [1]

14 days after intervention

Eligibility

Key inclusion criteria

healthy child between 9-22 months of age living in study area

Minimum age

9 Months

Maximum age

22 Months

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

no consent
residence outside of study area
known immunodeficiency

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

18/02/2019

Actual

Date of last participant enrolment

Anticipated

22/02/2019

Actual

Date of last data collection

Anticipated

30/03/2019

Actual

Sample size

Target

360

Accrual to date

Final

Recruitment outside Australia

Country [1]

Mozambique

State/province [1]

Funding & Sponsors

Funding source category [1]

Other

Name [1]

World Health Organization

Address [1]

20 Appia Avenue, 1211 Geneva

Country [1]

Switzerland

Primary sponsor type

Other

Name

WHO

Address

20 Appia Avenue, 1211 Geneva

Country

Switzerland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

WHO Ethics Review Committee

Ethics committee address [1]

20 Appia Avenue, 1211 Geneva

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

12/12/2018

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The attenuated poliovirus strains contained in oral polio vaccine (OPV) can re-acquire the neurovirulence and transmissibility of wild poliovirus in populations with low immunity. Because of the significant burden in paralytic cases caused by outbreaks of circulating vaccine-derived poliovirus (cVDPV), it was decided to switch from trivalent to bivalent OPV containing only type 1 and 3 polioviruses, and incorporate a dose of inactivated poliovirus vaccine (IPV) in routine immunization schedules.  Type 2 monovalent OPV (mOPV2) was reserved for use in response to potential VDPV2 outbreaks after the tOPV-bOPV switch in April 2016.  Unfortunately, the number and size of VDPV2 outbreaks observed after the switch has exceeded expectations and the mOPV2 available in the stockpile may be insufficient.  
A potential solution to stretch the mOPV2 stockpile would be giving 1 drop instead of the conventional 2 drops. The recommended content of Sabin poliovirus in a 2-drop dose of mOPV2 is at least 105 TCID50, but most batches include 2-4 times the minimum recommended amount. Therefore, half the dose of mOPV2 (i.e. 1 drop) could still induce appropriate immunogenicity. However, policy makers need clinical trials among children naïve to type 2 OPV before recommending a reduction in mOPV2 dose and trials can only be done in countries where mOPV2 can be legally used, which is those experiencing a VDPV2 outbreak, such as Mozambique.    

We will conduct a clinical trial in Mocuba district, Zambezia, Mozambique that will compare the immunogenicity against type 2 poliovirus of one drop versus two drops of mOPV2.  The results of this study will guide the Global Polio Eradication to develop strategies that prevent a devastating shortage in mOPV2.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nilsa de Deus

Address

Department of Research Instituto Nacional de Saude (INS), Mozambique Vila de Marracuene Estrada Nacional N°1, Parcela N°3943 Província de Maputo

Country

Mozambique

Phone

+258 21430814

Fax

[email protected]

Contact person for public queries

Name

Ondrej Mach

Address

World Health Organization 20 Appia Avenue, 1211 Geneva

Country

Switzerland

Phone

+41227911863

Fax

[email protected]

Contact person for scientific queries

Name

Ondrej Mach

Address

World Health Organization 20 Appia Avenue, 1211 Geneva

Country

Switzerland

Phone

+41227911863

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically